Product code PPT— Neurology

“Software and hardware for surgical planning to create patient-specific anatomical models, surgical templates, and guides for use in the marking or cutting of cranial bone for neurosurgical procedures.”

FDA has cleared 4 devices under product code PPT between 2016 and 2026, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20261 clearance
• 20201 clearance
• 20191 clearance
• 20161 clearance

• KLS-Martin L.P.2 clearances
• Materialise NV1 clearance
• 3D Systems, Inc.1 clearance

• K253308 — Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic ModelsMaterialise NV·2026-01-07
• K201052 — KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.·2020-08-31
• K182889 — KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.·2019-07-26
• K151285 — VSP Cranial System3D Systems, Inc.·2016-09-23